Documentation

Application Instructions

Prerequisites for submitting an application:

Investigators qualifications for initiating an application. Investigators must be permanent employees of their institution at a level equivalent to a full-time assistant, associate, or full professor senior scientist with responsibilities that most likely include laboratory administration and oversight. Laboratory staff and trainees such as graduate students, and postdoctoral fellows are not permitted to submit project requests.

Authentication. Submitting Investigators and their Institutional Signing Official must have an eRA Commons ID in order to log into the Data Sharing Service (DSS). The Signing Official’s eRA Commons ID is needed for the institution to sign and submit the application on the investigator’s behalf.

Prerequisite for accessing the data:

Investigators must have a current username and approved application with LONI. The Investigator will be able to log into the DSS and submit an application at any time, but LONI authentication will be needed before the requested data will be distributed. LONI login information can be entered when filling out your DSS profile.

Required Supplemental Documents:

The following are to be uploaded with your Data Access Request submission:

Derived/Secondary Data Return Plan. The Investigator must describe the derived/secondary data that will be returned to the NIA Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS): see Sample-Data-Return-NIAGADS.

The NIAGADS Data Distribution Agreement. This document must be signed by the Investigator and his/her Institutional Signing Official: see NIAGADS DDA.

The following is to be sent to NIAGADS via email:

Data Transfer Agreement (DTA). The DTA should be sent to NIAGADS via email in parallel with the submission of your DAR. The Principal Investigator is responsible for ensuring that all lab personnel with access to the data distributed by NIAGADS DSS sign the DTA. This includes all individuals (investigators, trainees, staff, graduate students, postdoctoral fellows, technicians, and internal collaborators). Each time a new lab member is hired or will access the data, this document needs to be updated with their signature and re-submitted. Please email the signed DTA to niagads@pennmedicine.upenn.edu for University of Pennsylvania to countersign.
NOTE: it must include your proposed research use statement as well as the project title and DAR ID generated after submission: see NIAGADS DTA. Principal Investigators from the University of Pennsylvania will need to submit a Personnel Data Protection Agreement in place of the DTA. The same conditions of the DTA apply to this document.

NOTE: All documents related to the application should be provided in English. For institutions where English is not the primary language, please provide translations of documents along with the original document. Translated documents should be signed by the institutional signing official.

External Collaborations:
Investigators can share data with collaborators outside of the PI’s institution. The collaborators must submit parallel project requests with (1) the same project title and (2) the same Research Use Statement and Cloud Use Statement, if applicable, that references the collaboration (for smaller collaborations, the name and institution of the collaborating PI(s) or for larger efforts, the consortium name). Data exchange between all collaborators must be consistent with the NIH Security Best Practices for Controlled-Access Data Subject to the Genomic Data Sharing (GDS) Policy and GDS Policy.

Signing Official Contact Information. A Signing Official (SO) has institutional authority to legally bind the institution in grants administration matters. The individual fulfilling this role may have any number of titles in the grantee organization. The label, “Signing Official,” is used in conjunction with the NIH eRA Commons. For most institutions, the SO is located in its Office of Sponsored Research or equivalent.

Research Use Statement (RUS). The statement should include the following components (2,200 characters max):

Objectives of the proposed research;

Study design;

Analysis plan, including the phenotypic characteristics that will be evaluated in association with genetic variants;

If applicable, a brief description of any planned collaboration with researchers at other institutions, including the name of the collaborator(s) and their institutions(s).

The NIAGADS ADRD Data Access Committee (NADAC) will review the RUS to confirm that the proposed research is consistent with all applicable data use limitations for the requested dataset(s).

Non-Technical Summary. This non-technical summary of your proposed research plan will be made publicly available for lay audiences to read (1,100 characters max).

Cloud Use Statement and Cloud Server Provider Information (if applicable). NIH notice of Cloud Computing– Investigators who wish to use cloud computing for storage and analysis will need to indicate in their Data Access Request (DAR) that they are requesting permission to use cloud computing and identify the cloud service provider or providers that will be employed. They also will need to describe how the cloud computing service will be used to carry out their proposed research, if applicable.

External Collaborator Contact Information. An external collaborator is a collaborator of the PI on this DAR who is not employed at the PI’s institution and has submitted a parallel application as described above. The external collaborators names and institution must be provided here.

Data Use Certification. By checking the box under this section, you are agreeing to the terms outlined in the Data Use Certification.